Anti-Adhesive Effect of GUARDIX-SL® after Intact Canal Wall Mastoidectomy: Preliminary Study
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Background and Objectives: Adhesion of middle ear and mastoid cavity after mastoidectomy represents a potential source of surgical failure. GUARDIX-SL®, absorbable anti-adhesive material, which is composed of sodium hyaluronate and sodium carboxymethyl cellulose, is an effective agent that widely used as a surgical adjuvant to decrease adhesion in the surgery. Therefore, we evaluated the clinical efficacy of the GUARDIX-SL® for the prevention of adhesion after mastoidectomy. Subjects and Methods: This study was randomized and double-blinded. Conventional intact canal wall mastoidectomy was conducted in both control (n=14) and study group (n=10). To avoid bias because of different surgeons, we only included patients who were operated on by one surgeon. In the study group, 1.5 g GUARDIX-SL® was applied in the mastoid cavity at the end of mastoidectomy. To evaluate anti-adhesive effect of GUARDIX-SL®, the volume of aerated area in the mastoid cavity was calculated and compared with temporal bone computed tomography performed at preoperatively and postoperatively. Besides, to assess the success of operation, pure tone audiometry was also performed at preoperatively and postoperatively. Results: The volume of aerated area of mastoid cavity after mastoidectomy was more increased in GUARDIX-SL® group, but was not statistically significant in the GUARDIX-SL® group than the control. And all results of pure tone audiometry satisfied the criteria of successful operation which has been suggested by Otological Society of Korea. Conclusion: The results suggest that GUARDIX-SL® may be an efficacious and safe material in decreasing the incidence of adhesion after mastoidectomy.
Abstract
Background and Objectives: Adhesion of middle ear and mastoid cavity after mastoidectomy represents a potential source of surgical failure. GUARDIX-SL®, absorbable anti-adhesive material, which is composed of sodium hyaluronate and sodium carboxymethyl cellulose, is an effective agent that widely used as a surgical adjuvant to decrease adhesion in the surgery. Therefore, we evaluated the clinical efficacy of the GUARDIX-SL® for the prevention of adhesion after mastoidectomy. Subjects and Methods: This study was randomized and double-blinded. Conventional intact canal wall mastoidectomy was conducted in both control (n=14) and study group (n=10). To avoid bias because of different surgeons, we only included patients who were operated on by one surgeon. In the study group, 1.5 g GUARDIX-SL® was applied in the mastoid cavity at the end of mastoidectomy. To evaluate anti-adhesive effect of GUARDIX-SL®, the volume of aerated area in the mastoid cavity was calculated and compared with temporal bone computed tomography performed at preoperatively and postoperatively. Besides, to assess the success of operation, pure tone audiometry was also performed at preoperatively and postoperatively. Results: The volume of aerated area of mastoid cavity after mastoidectomy was more increased in GUARDIX-SL® group, but was not statistically significant in the GUARDIX-SL® group than the control. And all results of pure tone audiometry satisfied the criteria of successful operation which has been suggested by Otological Society of Korea. Conclusion: The results suggest that GUARDIX-SL® may be an efficacious and safe material in decreasing the incidence of adhesion after mastoidectomy.
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